510(k) K063580
K063580 is an FDA 510(k) premarket notification submitted by Medison Co., Ltd. for the device "SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on December 14, 2006. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Medison Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2006
- Date Received
- November 30, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type